02/04/2026  |  Gareth Macdonald  |  Bio Xconomy

https://www.bioxconomy.com/clinical-and-research/proposed-biotech-act-would-help-eu-win-more-trials-says-ema 

The European drug regulator says new legislation will reduce bureaucracy and make the region more competitive for pharmaceutical research.

The proposed European Biotech Act would help sponsors start trials faster, encourage the use of AI, and harmonize data processing rules with the revised Declaration of Helsinki, according to the EMA.

The European drug industry regulator made the comments last week, arguing the Act—plans for which were unveiled in December—would make the EU a more attractive location for conducting trials of new drugs and therapies.

Rainer Becker, director, DG SANTE, European Commission, wrote: “The Act contains a broad range of measures to strengthen the EU’s biotech health ecosystem. These include a series of important improvements to the clinical trials framework to support innovation and the development of new treatments.”

One of these improvements will be to create a faster, simplified approval process for clinical trials with review timelines being reduced from around 106 days at present to 75 days—or even 47 days in cases where no additional information is requested.

In addition, timelines for assessing substantial modifications to a clinical trial application will also be shortened, from 96 to 47 days.

Another proposal is to remove the mechanism that currently allows reviewers to extend trial assessments by 50 days for advanced therapy medicinal products.

To support the revisions, the Act includes measures to expand the responsibilities of the reporting member state, which is the country nominated to lead the assessment of each trial applications submitted to the Clinical Trial Information System. 

“These accelerations will be made possible through an enhanced role of the reporting Member State, including an integrated and coordinated ethical review and by performing the validation and assessment of a clinical trial application in parallel,” Becker said.

Risk-proportionate approach
Another aim is to introduce a risk-proportionate approach to trial authorizations.

The Act states, “An enhanced application of a risk-proportionate approach will contribute to fostering a regulatory framework that is conducive to research and innovation.”

It continues, “Sponsors … will greatly benefit from simplified and risk-proportionate regulatory requirements through a reduced administrative burden, while not compromising subjects’ safety, well-being, and rights.”

The Act also seeks to align regulations more closely with the recently revised Declaration of Helsinki—the World Medical Association’s ethical guidelines for  medical research involving humans, including research on identifiable human material and data.